Senator Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) urge FDA commissioner Robert Califf to restrict patents that are listed in the Orange ...
FDA clears an ICU Medical 510(k) for the Plum Duo infusion pump with LifeShield infusion safety software.
Federal Register notice: FDA sends to OMB an information collection extension entitled Customer/Partner Service Satisfaction Surveys.
FDA approves 15 ANDAs representing the first generics of Takedas Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, indicated for at...
Janssen Pharmaceutical files a supplemental BLA seeking an expanded approval for Rybrevant (amivantamab-vmjw) combination use with chemotherapy (carb...
Boston Scientific reports positive 12-month results from its pivotal ADVENT clinical trial of the FaraPulse Pulsed Field Ablation System, a nonthermal...
A Flag Pharma citizen petition asks FDA to revisit the therapeutic equivalence ratings of generic drug products that relied on bioequivalence studies ...
FDA clears a BioProtect 510(k) for its BioProtect Balloon Implant System, a next-generation spacer designed to provide protection to the rectum during...
